BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 83 PLUS

    MDR report key: 6501054 · Received April 18, 2017

    Report

    Report Number
    3007082252-2016-00039
    Event Type
    Death
    Date Received
    April 18, 2017
    Report Date
    September 18, 2016
    Manufacturer
    CUSTOM ULTRASONICS, INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOM ULTRASONICS IS NOT AWARE OF A CU DEVICE BEING IN SERVICE AT THIS LOCATION, AS ALLEGED IN THE LEGAL DOCUMENTS.

    Description of Event or Problem · 1

    ADVERSE EVENT AS ALLEGED SOLELY IN LEGAL DOCUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284382 SYSTEM 83 PLUS ENDOSCOPE WASHER DISINFECTOR FEB CUSTOM ULTRASONICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death